May 8th 2024
Data from the ongoing phase 1/2 CHORD trial was presented at the ASGCT annual conference.
Advancing Care in Erosive Esophagitis: Towards a Path of Complete Healing
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Shaping the Management of COPD with Biologic Therapy
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Elevating Care for PAH: Applying Recommended Management Approaches to Maximize Outcomes
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Clinical Consultations™: Managing Depressive Episodes in Patients with Bipolar Disorder Type II
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Expert Illustrations & Commentaries™: Exploring the Role of Novel Agents for the Management of IgA Nephropathy
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Medical Crossfire®: Understanding the Advances in Bipolar Disease Treatment—A Comprehensive Look at Treatment Selection Strategies
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'REEL’ Time Patient Counseling: The Diagnostic and Treatment Journey for Patients With Bipolar Disorder Type II – From Primary to Specialty Care
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Clinical ShowCase™: Finding the Best Path Forward for Patients with COPD
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A Tethered Approach to Type 2 Diabetes Care – Connecting Insulin Regimens with Digital Technology
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Surv.AI Says™: What Clinicians and Patients Are Saying About Glucose Management in the Technology Age
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Patient, Provider & Caregiver Connection™: Implementing an Effective Management Plan to Improve Outcomes in IgA Nephropathy
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Axatilimab meets primary outcome in phase 2 chronic graft versus host disease trial
July 25th 2023Results from a pivotal phase 2 clinical trial revealed axatilimab met the primary outcome in all cohorts for graft versus host disease (GVHD) in pediatric and adult patients. Based on its safety and efficacy profile demonstrated in clinical trials, Syndax and Incyte intend to file a biologics license application (BLA) for axatilimab with the FDA by the end of 2023.
Pfizer announces phase 2 data of Group B Streptococcus vaccine candidate
July 20th 2023According to Pfizer, the investigational vaccine to protect against Group B Streptococcus (GBS) generated maternal antibody responses against 6 capsular polysaccharide serotypes and efficiently transferred antibodies to the infants. The announcement of this phase 2 data comes in July, which is International Group B Streptococcus Month.
Nirsevimab-alip FDA approved to prevent RSV in neonates, infants
July 17th 2023The approval follows a unanimous vote of support from the FDA Antimicrobial Drugs Advisory Committee of nirsevimab-alip’s favorable benefit-risk profile for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants amid their first RSV season.
Advancements in FDA approvals for pediatric obesity treatment
GLP-1 receptor agonists, used to treat diabetes, are now also being used for obesity in children and adolescents.
CAP-1002 demonstrates positive phase 2 results to treat Duchenne muscular dystrophy
June 30th 2023Improvement in the left ventricular ejection fraction (LVEF) and statistically significant benefit in the Performance of the Upper Limb (PUL v2.0) scale were observed following 2 years of CAP-1002 treatment in Duchenne muscular dystrophy (DMD) patients.
FDA accepts NDA for givinostat to treat Duchenne muscular dystrophy
June 29th 2023According to Italfarmaco Group, a New Drug Application (NDA) for givinostat has been accepted and granted priority review by the FDA to treat Duchenne muscular dystrophy (DMD) patients, following positive topline phase 3 trial results.
FDA approves somatrogon-ghla to treat pediatric growth hormone deficiency
June 28th 2023Indicated for growth hormone deficiency (GHD) patients aged 3 years and older, somatrogon-ghla is now FDA-approved to treat GHD following positive phase 3 data demonstrating non-inferiority, measured by annual height velocity at 12 months, compared to somatropin.
FDA approves empagliflozin, empagliflozin plus metformin for pediatric type 2 diabetes
June 21st 2023Children 10 years and older with type 2 diabetes (T2D) can now be treated with empagliflozin and empagliflozin plus metformin hydrochloride to improve blood sugar control, per a recent approval by the FDA.
FDA approves adalimumab-adbm autoinjector pen for JIA, Crohn’s disease
May 22nd 2023Patients using adalimumab-adbm for chronic inflammatory disease treatment such as juvenile idiopathic arthritis (JIA), Crohn’s disease, and others, will have an autoinjector option beginning July 1, 2023, according to Boehringer Ingelheim.
Tapinarof cream 1% demonstrates positive topline results for treating pediatric AD
May 16th 2023The once-daily topical cream for the treatment of atopic dermatitis (AD) has demonstrated positive topline results in 2 phase 3 studies in adults and children aged 2 years and up. According to Dermavant, a supplemental new drug application (sNDA) filed with the FDA is anticipated in Q1 of 2024.
FDA approves scoliosis correction system for pediatric idiopathic scoliosis
May 16th 2023The REFLECT Scoliosis Correction System from Globus Medical is intended to correct progressive scoliosis in pediatric patients while simultaneously maintaining stability and motion as well as allowing for future modulated growth.
FDA approves 20-valent pneumococcal conjugate vaccine for infants 6 weeks and older
April 28th 2023According to Pfizer, the company’s pneumococcal conjugate vaccine Prevnar 20 has been approved by the FDA to treat infants and children aged 6 weeks to 17 years for the prevention of invasive pneumococcal disease (IPD).
Emapalumab induces remission of macrophage activation syndrome
April 27th 2023According to a phase 2 study, remission of macrophage activation syndrome (MAS) secondary to systemic juvenile idiopathic arthritis (sJIA) or adult-onset Still’s disease (AOSD) was achieved in patients taking emapalumab who failed high-dose glucocorticoids.
FDA accepts NDA for roflumilast foam 0.3% for seborrheic dermatitis in 9 years and up
April 18th 2023Roflumilast is a once-daily, topical phosphodiesterase type 4 (PDE4) inhibitor under development for treatment of inflammatory dermatoses, focusing on the hair-bearing areas including the face, scalp, and trunk.
FDA extends approval of Evkeeza for homozygous familial hypercholesterolemia in young children
March 22nd 2023Evkeeza is the first angiopoietin-like 3 (ANGPTL3) inhibitor indicated for patients as young at 5 years to control high levels of low-density lipoprotein cholesterol (LDL-C) as a result of HoFH.